Abstract

Background

Neck pain is a common symptom in most patients suffering from cervical radiculopathy.
However, some conservative treatments are limited by their modest effectiveness. On
the other hand, surgical intervention for cervical disc disorders is indicated when
symptoms are refractory to conservative treatments and neurological symptoms are progressive.
Many patients use complementary and alternative medicine, including traditional Chinese
medicine, to address their symptoms. The purpose of the present study is to examine
the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine,
for neck pain in patients with cervical radiculopathy.

Methods/design

A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the
efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients
from five sites across China and diagnosed with cervical radiculopathy, according
to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck
for at least 2 weeks (neck disability index score 25 or more) and accompanying arm
pain that radiates distally from the elbow. Qualified participants will be randomly
allocated into two groups: Qishe Pill group and placebo group. The prescription of
the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive
days. The primary outcome is pain severity. Secondary outcomes are functional status,
patient satisfaction, and adverse events as reported in the trial.

Discussion

Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to
improve on the various symptoms of cervical radiculopathy, especially for neck pain.
As it has a potential benefit in treating patients with neck pain, we designed a double-blind,
prospective, randomized-controlled trial and would like to publish the results and
conclusions later. If Qishe Pill can alleviate neck pain without adverse effects,
it may be a unique strategy for the treatment of cervical radiculopathy.